Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Completed

• Conditions: Acute Kidney Injury; Depression
• Interventions: Drug: Duloxetine; Drug: Citalopram; Drug: Escitalopram; Drug: Venlafaxine; Drug: Desvenlafaxine; Drug: Fluoxetine; Drug: Fluvoxamine; Drug: Paroxetine; Drug: Sertraline

• Registration Number: NCT02320240
• Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES

Brief Summary

The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of depression.

Detailed Description

We plan to conduct retrospective population-based cohort studies within eight administrative databases from Canada, the United States, and the United Kingdom. Within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (RR) of AKI associated with SNRIs compared to SSRIs using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. The overall effect across sites will then be estimated using meta-analytic methods.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3255526

Inclusion Criteria

• A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.

Exclusion Criteria

• They were <12 years old at the time of cohort entry.
• They had less than 1 year of information in the database prior to the date of cohort entry.
• They had a prescription of an SNRI or SSRI in the year before the date of cohort entry.
• They had a prescription for both an SNRI and an SSRI on the day of cohort entry.
• They had a history of chronic kidney disease (including kidney transplantation and dialysis) or AKI in the year preceding cohort entry.
• The subject was previously included in the cohort.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SNRI Exposure Group	Desvenlafaxine	Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.
SNRI Exposure Group	Duloxetine	Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.
SSRI Exposure Group	Escitalopram	Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.
SNRI Exposure Group	Venlafaxine	Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.
SSRI Exposure Group	Fluoxetine	Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.
SSRI Exposure Group	Citalopram	Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.
SSRI Exposure Group	Fluvoxamine	Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.
SSRI Exposure Group	Paroxetine	Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.
SSRI Exposure Group	Sertraline	Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury (AKI)	2 years	AKI will be defined as patients hospitalized with one of the following diagnosis codes for AKI in any of the listed diagnoses: ICD-9-CM codes 584, 584.5, 584.6, 584.7, 584.8, or 584.9; ICD-10 N17, N17.0, N17.1, N17.2, N17.8, or N17.9.

Trial Locations

Locations (1)

Lady Davis Institute for Medical Research, Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada